Notification by sponsor and/or investigator to regulatory authorities and IRB/IECs of unexpected serious adverse drug reactions and other safety information is intended for which recipients?

• A. Investigators only
• B. Regulatory authorities and IRB/IECs
• C. Sponsor only
• D. Subjects

Answer: (B)

When safety information is unexpected and serious, it must be shared with those who oversee trial safety and ethics: regulatory authorities and the IRB/IEC that approved the study. This allows independent oversight and timely regulatory action to protect participants. The sponsor is responsible for sending these reports, with investigators reporting as required, but the formal recipients are the regulators and the IRB/IEC. Subjects aren’t the formal recipients of these safety reports; they’re informed through consent updates and communications, while the official safety reporting goes to the oversight bodies.